Pharmacokinetic profile of cabazitaxel in study population [ Time Frame: Up to day 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety profile of cabazitaxel in study population, as measured by adverse events, clinical, laboratory and ECG parameters [ Time Frame: up to 30 days after the last dosing ] [ Designated as safety issue: No ]

The study consists of a screening phase, registration, cabazitaxel administration will start within 5 business days of registration, with 21-day study treatment cycles. Cycle lengths may be extended up to a maximum of 14 additional days in case of unresolved toxicity. Patients continue to receive treatment until they experience, unacceptable toxicities/Adverse Events, disease progression, withdraw their consent, or the investigator decides to discontinue the patient, and the subsequent 30 days follow-up or study cut-off, whichever comes first.

Patients may continue to be treated as long as they are benefiting from study treatment and have not met study withdrawn criteria.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion criteria :

Diagnosis of histologically or cytologically proven non-hematologic malignancy. The cancer must be one that is either refractory to standard therapy or for which no standard therapy exists. Cabazitaxel is an adequate treatment option, as judged by investigator.

Eastern Cooperative Oncology Group performance status 0 - 2

Stable renal function

Patients must have adequate liver and marrow function as defined below:

Absolute neutrophil count ≥ 1.5x10^9/L

Platelets ≥ 100x10^9/L

Total bilirubin ≤ 1.0 x the institutions upper limit of normal

AST (SGOT)/ALT (SGPT) ≤ 2.5 x the institutions upper limit of normal

Alkaline phosphatase ≤ 2.5 x the institutions upper limit of normal

Patient may have a Grade 1 or less neurotoxicity at study entry.

Life expectancy > 3 months

Age ≥ 18 years old

If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal.

Having given written informed consent prior to any procedure related to the study

Exclusion criteria:

Less than 4 weeks have elapsed from prior anticancer therapy (surgery, chemotherapy, radiation therapy, hormonal therapy and immunotherapy). Prior isotope therapy and radiotherapy to ≥ 30% of bone marrow are not allowed.

Any treatment known to induce CYP isoenzymes (e.g., phenobarbital, phenytoin, carbamazepine, rifampicin, St John's Wort) or to strongly inhibit CYP3A4 activities (e.g., ketoconazole, itraconazole, macrolides, antiprotease agents, etc) is not allowed within 2 weeks before or during the test period of the pharmacokinetic sampling

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527929